Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Data available after Linde and Ikaria have been informed and granted permission
Additional strain / cell type characteristics:
other: Data available after Linde and Ikaria have been informed and granted permission
Test concentrations with justification for top dose:
2.5 to 70% (v/v)

Results and discussion

Test results
Species / strain:
other: Data available after Linde and Ikaria have been informed and granted permission
Metabolic activation:
with and without
Genotoxicity:
other: Data available after Linde and Ikaria have been informed and granted permission
Cytotoxicity / choice of top concentrations:
other: Data available after Linde and Ikaria have been informed and granted permission
Vehicle controls validity:
other: Data available after Linde and Ikaria have been informed and granted permission
Untreated negative controls validity:
other: Data available after Linde and Ikaria have been informed and granted permission
Positive controls validity:
other: Data available after Linde and Ikaria have been informed and granted permission
Remarks on result:
other: other: Data available after Linde and Ikaria have been informed and granted permission
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Data available after Linde and Ikaria have been informed and granted permission.

Applicant's summary and conclusion